**Company Description**
Position based in Mexico.
Role Overview
Key Responsibilities
- Collaborate with statisticians to develop, review, and approve Statistical Programming Plans (SPP). Implement Statistical Analysis Plans (SAP) and SPP to create ADaM data specifications.
- Program and validate ADaM and statistical analyses using programming languages (e.g., SAS, R), ensuring adherence to established standards and guidelines.
- Generate tables, listings, and figures (TLFs) for clinical study reports, safety reports, and other deliverables, ensuring accuracy, consistency, and adherence to regulatory requirements.
- Develop and maintain programming documentation, such as annotated program code, programming specifications, and validation plans.
- Perform quality control checks on statistical programming deliverables to ensure accuracy, consistency, and adherence to programming standards.
- Collaborate with cross-functional teams to support ad hoc data analyses, data visualization, and exploratory analyses as needed.
- Assist in the development and implementation of standard programming macros, utilities, and tools to improve efficiency and consistency in programming tasks.
- Stay updated with industry best practices, regulatory guidelines, and emerging technologies in statistical programming and data analysis.
- Support the planning and execution of statistical programming-related audits, inspections, and regulatory submissions, ensuring compliance with relevant regulations and guidelines.
- Collaborate with statisticians and study teams to provide programming support, address data-related queries,



and contribute to study-related publications.
**Qualifications**
- Master's degree with 4+ years of experience or Bachelor’s degree with 6+ years of experience in statistics, computer science, engineering, or a related field.
- Understanding of statistical methods, data analysis techniques, and clinical research processes.
- Proficiency in programming languages commonly used in statistical programming, such as SAS or R.
- Knowledge of CDISC standards.
- Basic understating of drug development process with emphasis on clinical study life cycle.
- Familiarity clinical study protocols, statistical analysis plans (SAPs), tables, listings, and figures (TLFs), and statistical programming documentation.
- Experience in generating TLFs, programming macros, and data manipulation using SAS or other statistical programming languages.
- Strong attention to detail and problem-solving skills, with the ability to identify and troubleshoot programming issues.
- Proficiency in using statistical software and programming tools, such as SAS, R, and SQL.
- Effective communication skills, both written and verbal, with the ability to interact professionally with statisticians, study teams, and external partners.
- Ability to work collaboratively in a team environment and adapt to changing priorities and deadlines.
- Experience in statistical programming or clinical research, either through internships, academic research projects, or previous employment, is a plus.
**Additional Information**
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

📌 Statistical Analyst (Remote) (Ciudad de México)
🏢 Abbvie
📍 Ciudad de México